Re: ASN late breaker and CKD sub-study top-line
in response to
by
posted on
Oct 10, 2019 10:05AM
What if apabetalone smashes MACE incidence in the baseline eGFR<60 subgroup AND the CKD sub-study shows that apabetalone significantly increases eGFR in those with baseline eGFR<60? Diabetic CKD is a high risk population.
While it will be great if it happens I'm not even sure that Apabetalone needs to smash MACE in the pre specified CKD group. Even if all this trial shows is medically significant improvement in kidney function in this group it might warrant approval just for that. Especially if kidney function in this group is showing a continued longer term improvement trend with time on drug. A more relevant follow up study in this case might be a study seeing if while on Apabetalone the improvement in kidney function, among other things, prevents a first MACE event in a specified CKD group that is at risk?
As others have pointed out the CKD market is massive and is projected to grow in a very significant manner. CKD affects an estimated that 37 million Americans. Currently the CKD patient population is limited to treatments that at best only slow down the progress of the disease. If Apabetalone shows it can stop or reverse the disease this will be an enormous opportunity both from the perspectives of better patient outcomes and the potetially astronomical cost savings to healthcare systems.
wrt topline data I'm hoping that we see that the trial shows that the MACE occurrences were trending increasingly lower in the test group as compared to placebo, as patients spend more time on drug and that the trial needed to be larger and longer to obtain statistical significance.